Multiple Myeloma Clinical Trial

Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma

Summary

The purpose of this study is to determine 1) the safety and tolerability of multiple intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.

View Eligibility Criteria

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Subjects must have confirmed diagnosis of multiple myeloma with measurable disease Excluded are subjects with only plasmacytomas, plasma cell leukemia, or non-secretory myeloma.
Disease must be assessed within 28 days prior to treatment initiation.
Subjects must have evidence of relapsed or relapsed/refractory disease.
Subjects must have received at least 2 prior regimens for multiple myeloma.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2.
Subjects must have received last treatment (ie, chemotherapy, radiotherapy, biological, immunotherapy or investigational agent [therapeutic or diagnostic]) at least 14 days prior to treatment initiation. The last treatment of systemically absorbed steroids must be at least 2 weeks or 5 half lives (whichever is shorter) before the first dose of BMS-936564.

Exclusion Criteria:

A serious uncontrolled medical disorder or active infection.
Current or recent (within 3 months) gastrointestinal disease or condition that could impact the absorption of orally-administered drug.
Inability to swallow oral medication.
Uncontrolled or significant heart disease.
Any other malignancy, excluding basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

46

Study ID:

NCT01359657

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 4 Locations for this study

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H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
University Of Kansas Cancer Center And Medical Pavillion
Westwood Kansas, 66205, United States
Dana Faber Cancer Institute
Boston Massachusetts, 02215, United States
University Of Washington School Of Medicine
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

46

Study ID:

NCT01359657

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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